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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074596

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NDA 074596 describes ACYCLOVIR SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Zydus Pharms Usa Inc, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Teva Parenteral, Hikma Pharms, Athenex Inc, and Apothecon, and is included in fifteen NDAs. It is available from seven suppliers. Additional details are available on the ACYCLOVIR SODIUM profile page.

The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for NDA: 074596

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 074596

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 074596

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION 074596 ANDA RedPharm Drug Inc. 67296-0375 67296-0375-1 20 TABLET in 1 BOTTLE (67296-0375-1)
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION 074596 ANDA RedPharm Drug Inc. 67296-0375 67296-0375-2 30 TABLET in 1 BOTTLE (67296-0375-2)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Apr 22, 1997TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Apr 22, 1997TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Accenture
Fish and Richardson
Moodys
McKinsey
Fuji
Julphar
Deloitte
US Department of Justice
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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